Status:
RECRUITING
Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy
Lead Sponsor:
IRCCS Ospedale San Raffaele
Conditions:
Diabetic Retinopathy
Diabetic Retinopathy Associated with Type 2 Diabetes Mellitus
Eligibility:
All Genders
40-80 years
Brief Summary
Despite the evidence that diabetic retinopathy (DR) remains the first cause of blindness among the working-age population, it lacks a specific preventive treatment. This is because early mechanisms le...
Detailed Description
The project is centered on a clinical study aimed to clarify whether early, diabetes-driven neurodegeneration (something that has been demonstrated by several seminal studies) is related (possibly cau...
Eligibility Criteria
Inclusion
- Inclusion Criteria - Longitudinal study (patients):
- Participant is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 40 - 80 years;
- In good general health as evidenced by medical history or diagnosed with type 2 diabetes for less than 10 years without clinical signs of retinopathy and other diabetic complications;
- HbA1c level 7% or greater;
- Inclusion Criteria - Longitudinal study (healthy controls)
- Participant is willing and able to give informed consent for participation in the trial;
- Male or Female, aged 40 - 80 years;
- In good general health as evidenced by medical history without diagnosis of type 2 diabetes;
- Inclusion Criteria - Cross-sectional study
- Participant is willing and able to give informed consent for participation in the trial;
- Male or Female, aged 40 - 80 years;
- Patient with a diagnosis of type 2 diabetes for longer than 20 years in the absence or presence of clinical signs of retinopathy and other diabetic complications;
- HbA1c level 7% or greater.
- Exclusion Criteria (longitudinal study and cross-sectional study)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- retinal or systemic diseases other than diabetes;
- hypertension (BP values greater than 140/90 mm Hg);
- anemia (hematocrit less than 35%);
- smoking;
- laser treatment and pregnancy
Exclusion
Key Trial Info
Start Date :
September 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 19 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06582472
Start Date
September 29 2023
End Date
May 19 2025
Last Update
September 3 2024
Active Locations (2)
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1
Irccs Ospedale San Raffaele
Milan, Italy/milan, Italy, 20132
2
IRCCS Ospedale San Raffaele _O.U. Ophthalmology
Milan, Italy, Italy, 20123